Nuwellis, Inc. · NASDAQ:NUWE
Nuwellis — CHF Solutions — IPO Roadshow (January 2020)
29 slides from Nuwellis's IPO roadshow presentation, Jan 8, 2020
Slide 1: Corporate Presentation (NASDAQ: CHFS) January 2020
Corporate Presentation (NASDAQ: CHFS)January 2020 For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 1
Slide 2: Safe Harbor Statement
Safe Harbor Statement For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 2 This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities and Exchange Act, as amended rega
Slide 3: Risk factors
Investing in our securities includes a high degree of risk. You should consider carefully the specific factors discussed below, together with all ofthe other information contained in our SEC filings. If any of the following risks actually occurs, our business, financial condition, results ofoperatio
Slide 4: Statement about Free Writing Prospectus
Statement about Free Writing Prospectus For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 4 This presentation highlights basic information about us and the offering. Because it is a summary that has been prepared solely for informational purposes, it does not contain all
Slide 5: Our Vision
Our Vision For Investor Purposes Only: Not For Product Promotion 5©2020 CHF Solutions, Inc. For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. CHF Solutions is dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and in
Slide 6: Addressable Target Segments
6 For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. Addressable Target Segments 1. Subject to FDA 510(k) clearance Critical CareCV Surgery (VAD, CABG, HV)*Liver (Transplant, Disease)SepsisAdult ECMO*strategic entry poin t Heart FailureInpatientOutpatient urgery nts Pedia
Slide 7: Upcoming Key Milestones
Upcoming Key Milestones Upcoming Key Milestones For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 7 Expected Timing Q1 2020 FDA 510(k) clearance of:Expanded use in pediatric population (≥ 20kg)Next generation Aquadex SmartFlow™ consoleReceive CE mark for Aquadex SmartFlo
Slide 8: Next Generation Aquadex
Simple Easy set-up and monitoring allowing for a 4:1 nurse to patient ratio Flexible Deliver safe and precise therapy with the ability to adjust the fluid removal rate and volume to meet each patient’s clinical need Smart Filter Alert prompts action to extend life and reduce therapy timeHct informs
Slide 9: Competitive Landscape
Competitive Landscape Ultrafiltration (Dedicated) Pediatrics Ultrafiltration Critical Care – Continuous Renal Replacement Therapy (“CRRT”) U.S. / Int’l Approval Pending 510(k) (est. early 2020) & Int’l Approval Potential for more effective treatment with Aquadex - - U.S. / Int’l Approval - - U.S. /
Slide 10: Pediatric Opportunity
Pediatric Opportunity “For our babies born with diseased or absent kidneys, Aquadex has given them a chance at life because in the past, there were no options to treat these patients.”Kara Short, MSN, CRNP, NICU nurse practitioner at Alabama Children’s Hospital For Investor Purposes Only: Not For Pr
Slide 11: Pediatrics: Providing a Solution in an Underserved Market
Pediatrics: Providing a Solution in an Underserved Market https://www.ncbi.nlm.nih.gov/pubmed/23833312https://www.cdc.gov/ncbddd/heartdefects/data.htmlhttps://www.ncbi.nlm.nih.gov/pubmed/23246046.https://www.organdonor.gov/about/donors/child-infant.html.http://www.heartviews.org/article.asp?issn=199
Slide 12: Aquadex is Providing Pediatric Patients Benefit
Attributes Grp 1: <10 kg Grp 2: 10-20kg Grp 3: >20 kg # of patients N=72 N=13 N=34 Median age 19 days 26 months 190 months Median weight at therapy onset 4.1 kg 15.1 kg 60.1 kg Primary disease 43% kidney 54% kidney 38% kidney 29% cardiac 31% other 38% cardiac Predominant indication 46% Volume overlo
Slide 13: Children's of Alabama – Pioneer of Aquadex Use in Pediatrics
Children’s of Alabama – Pioneer of Aquadex Use in Pediatrics Pediatric use of the Aquadex FlexFlow was first introduced at Children’s of Alabama in 2016 by Dr. David Askenazi1Today, 97% of therapy initiations occur without hemodynamic changes, meaning that the hospital gets pediatric patients on the
Slide 14: Pediatric Opportunity, Pipeline & Regulatory Status
14 For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. Pediatric Opportunity, Pipeline & Regulatory Status The Aquadex FlexFlow is being used in 24 metro areas in the U.S. for pediatric use without sales and marketing by CHF Solutions (pending 510(k) clearance for pediatri
Slide 15: Joe DiMaggio Children's Hospital Uses Aquadex FlexFlow With ECMO
15 For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. Joe DiMaggio Children’s Hospital Uses Aquadex FlexFlow In Tandem With ECMO In Pediatric Patients Extracorporeal Membrane Oxygenation (ECMO) is an advanced form of life support that does the work of the heart and lungs
Slide 16: Critical Care Opportunity
Critical Care Opportunity For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 16
Slide 17: Critical Care: Ultrafiltration Critical to Success in Fluid Overloaded Patients
Many large-volume hospitals use Aquadex FlexFlow as a treatment for fluid overload in the ICU settingThe clinical reason for fluid overload in critically ill patients is related to the requirement for fluid resuscitation (infusion of fluids to maintain hemodynamics)In a retrospective study of Aquade
Slide 18: Critical Care Growth Opportunities
Critical Care Growth Opportunities Cardiac Surgery(Valves, CABG)Liver Transplants VAD Adult ECMO Sepsis Liver Disease 520,000 patients/year1 8,000 patients/year2 - Emerging use in indication- Independent clinical data being generated Evaluating market Sepsis 1.7m patients/year4 Liver Disease 650,000
Slide 19: Acute Need in Cardiac Surgery: Fluid Overload and Mortality
Acute Need in Cardiac Surgery: Fluid Overload is Associated with Greater Mortality Retrospective analysis on 1,358 patients who underwent cardiac surgery Greater amount of IV fluid during cardiac surgery associated with three-fold increase in mortality at 90 days Fluid Overload is Associated with 30
Slide 20: Aquadex FlexFlow Clinical and Economic Benefits in CV Surgery
Aquadex FlexFlow Provides Significant Clinical and Economic Benefits in CV Surgery Modified ultrafiltration reduces duration of assisted ventilation post cardiac surgery1,2,3Ultrafiltration associated with decreases in certain post-operative complications4,5,6,7Aquadex FlexFlow not considered renalr
Slide 21: Heart Failure Opportunity
Heart Failure Opportunity For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 21
Slide 22: Heart Failure Opportunity in the 30 Days Readmission Population
Over 1 million heart failure (“HF”) hospitalizations annually in the US and 90% of these are due to fluid overload168% show sub-optimal response, 40% exhibiting diuretic resistance (“failure”)3. Nearly 50% of patients are discharged with residual excess fluid1Worsening heart failure with increased m
Slide 23: Outpatient Opportunity Update: Tampa VA Clinical Study
Tampa VA Clinical Study on Outpatient Use of AquadexGoal: Manage HF patients proactively to avoid 30-day readmissions$6.5M blanket purchase agreement received for outpatient trialAquadex FlexFlow vs. IV diuretics in outpatient settingProspective, randomized 80 patient studyQ2 2020 initiation - IRB A
Slide 24: Expanding Commercial Distribution
US direct sales team of 13 sales territories and 14 clinical education specialistsDistribution partners in UK, Italy, Germany, Spain, Greece, Singapore, Hong Kong, Thailand, India & Brazil Expanding Commercial Distribution In Q3/Q4 2019, we refocused our sales force towards the cardiac surgery and p
Slide 25: Financials & Capitalization
Financials & Capitalization For Investor Purposes Only: Not For Product Promotion©2020 CHF Solutions, Inc. 25
Slide 26: Financial Metrics
Financial Metrics US Pediatric Revenue as % of US Product Revenue $ in 000s Q3 2019: clinical pediatric publicationQ3-Q4 2019: commenced salesforce refocus to cardiac surgery and pediatrics 2019 Quarterly Revenue 2019 Quarterly Gross Margin Note: Q4 2019 numbers are preliminary Comments For Investor
Slide 27: Comparable Pediatric and Critical Care Companies
Comparable Pediatric and Critical Care Companies 89% discount for a company with U.S. product sales, no debt, an FDA approved device and an additional indication pending clearance Pediatric/ critical care nitric oxide delivery deviceNot FDA approved Market Cap + Debt ($0.3M) = $91M1 LTM Product Sale
Slide 28: Capitalization as of December 31, 2019
Capitalization as of December 31, 2019 Common Stock or Equivalents Common Shares Outstanding (Nasdaq CHFS) 4,674,068 Series F Convertible Preferred1 538,210 Options (weighted average exercise price $21.56) 405,730 Warrants2 (weighted average exercise price $7.06) 6,948,466 Fully Diluted Shares 12,56
Slide 29: CHF Solutions Investment Considerations
Medical device company with near- and long- term growth opportunities:Pediatrics: providing a solution to an underserved market; seeking 510(k) clearanceCardiac Surgery & Critical Care: Leveraging acute need to reduce mortality and drive adoption with clinical/economic benefitsHeart Failure: Largest